9Line— 510(k) K211941

Substantially Equivalent

Energetic Designs, Inc.

FDA 510(k) clearance K211941 for 9Line, Substantially Equivalent on 2022-01-27. Applicant: Energetic Designs, Inc..

Clearance details

Applicant: Energetic Designs, Inc.
Product code: Code DSA
Advisory panel: Cardiovascular
Date received: 2021-06-23
Decision date: 2022-01-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Broomfield, CO, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code DSA

product code DSA

Death: 2
Total: 2

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.